Study comparing the standard administration of immunotherapy (IO) versus the same agent administered each three months in patients with metastatic cancer in response after 6 months of standard IO

Phase 1

• Conditions: Oncologic metastatic tumour (lung cancer (K), renal cell K (except IMDC favorable-risk treated TKI / immunotherapy [IO] combination), head and neck K, bladder K, triple negative breast K, Merkel K and melanoma, or hepatocellular carcinoma) in PR or CR (except for melanoma, only patients in partial response) after 6 months of standard IO treatment (monotherapy or previously in combination with other immunotherapy or chemotherapy or continuous combination with pemetrexed or bevacizumab or TKI).; MedDRA version: 20.0Level: LLTClassification code 10025044Term: Lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10038407Term: Renal cell cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10064025Term: Merkel cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cyst; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000615-23-FR
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-14
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 646

Inclusion Criteria

1.Patients must have signed a written informed consent form prior to any trial specific procedures.
2.Patient aged =18 years old.
3.Initial metastatic disease histologically confirmed including : lung cancer, renal cell cancer, head and neck cancer, bladder cancer, triple negative breast cancer, Merkel cancer, hepatocellular carcinoma and melanoma.
4.Patients in partial or complete response after 6 months of standard immunotherapy (whatever the line of therapy) according to the RECIST (confirmed by local radiological assessment). For metastatic melanoma only patients in partial response.
5.Eligible to maintain the same standard IO treatment.
6.Patient with ECOG performance status =1.
7.Patients with brain metastases are allowed, provided they are stable according to the following definitions: treated with surgery or stereotactic radiosurgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.
8.Patients treated by IO previously combined with chemotherapy are allowed.
9.Patients with TKI-IO or pemetrexed-IO or bevacizumab-IO are allowed.
10.Evidence of post-menopausal status, or negative urinary or serum pregnancy test for pre-menopausal patients.
11.Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use adequate contraception method for the duration of the study treatment and after completing treatment according to the most recent version of the IO SmPC.
12.Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
13.Patient must be affiliated to a Social Security System.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 396

Exclusion Criteria

1.Metastatic melanoma in complete response.
2.Metastatic renal cell carcinoma with IMDC favourable-risk treated TKI/IO combination.
3.Hematologic malignancies (leukaemia, myeloma, lymphoma…)
4.Active infection requiring systemic therapy.
5.Patients enrolled in another therapeutic study within 30 days before the inclusion in and during MOIO study.
6.Patient unable to comply with study obligations for geographic, social, or physical reasons, or who is unable to understand the purpose and procedures of the study.
7.Person deprived of their liberty or under protective custody or guardianship.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified